Phase 3 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with advanced (metastatic) non-small cell lung cancer (NSCLC), confirmed by a laboratory test on a tissue or cell sample. People with stage III disease may also be considered if surgery or combined chemotherapy-and-radiation treatment is not an option for them. (Note: people with a specific subtype called Large Cell Neuroendocrine Carcinoma are not eligible.)
• People whose cancer has been tested and confirmed to be negative for two specific genetic changes known as EGFR and ALK mutations.
• People who have a laboratory test result showing that their tumour has a high level of a protein called PD-L1, with a score of 50% or above. People with a lower PD-L1 score who are already receiving a single-agent immunotherapy drug called pembrolizumab in line with local treatment guidelines may also be considered after discussion with the trial team.
• People who have signed up to the trial before starting immunotherapy, and who have a detectable level of tumour DNA in their blood (called ctDNA) at around 6 weeks into pembrolizumab treatment.
• People who received chemotherapy or immunotherapy before their cancer spread (for example, as adjuvant or neoadjuvant therapy), provided that treatment finished at least 6 months before starting pembrolizumab for metastatic disease. Local radiation therapy is allowed if it was completed at least 2 weeks before the blood test for ctDNA (no waiting period is required for people who received radiation to the brain).
• People who have recovered from side effects of any previous cancer treatment to a mild level or better.
• People who have had major surgery, provided it took place at least 14 days before the ctDNA blood test and at least 28 days before joining the trial, and that wounds have healed.
• People who are considered medically suitable to continue pembrolizumab, or to have chemotherapy added to pembrolizumab, and who are clinically stable without signs of their cancer getting rapidly worse. Access to pembrolizumab must be available at the trial site — if the site is unable to provide the drug, eligibility cannot be met.
• People aged 18 or older.
• People with a general health and activity level rated 0, 1, or 2 on a standard scale used by doctors (called the ECOG performance status), meaning they are fully active to capable of limited self-care.
• People who have cancer that can be seen and assessed on scans, even if it does not meet the strictest definition of "measurable."
• People who have had recent imaging scans (CT of the chest, abdomen and pelvis, and brain scans if brain spread is known) completed within 14 days before being randomly assigned to a treatment group, showing that the cancer has not progressed in a way that would require a change in treatment.
• People whose cancer is either stable or not progressing on scans (or is progressing but the treating doctor considers it safe to continue immunotherapy), confirmed before joining the trial.
• People with blood test results showing that the liver, kidneys, and blood cell counts are at levels considered adequate for continuing immunotherapy or receiving standard platinum-based chemotherapy.
• People who agree to provide a stored tumour tissue sample (if one is available) for research analysis.
• People who have given written consent to have blood samples taken for ctDNA testing and research, and to being randomly assigned to a treatment group if ctDNA is detected.
• People who are able to attend all required treatment visits, blood sample collections, and follow-up assessments at the trial site.
• People of childbearing potential who agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose. Male participants with partners who could become pregnant must agree to use condoms (with spermicide if available) along with an additional effective contraceptive method used by their partner, for the same period.

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that are causing symptoms, or that require high doses of steroid medication (more than 10 mg per day of prednisone or equivalent) to manage. People with brain metastases that are not causing symptoms and are managed on a low, stable steroid dose may still be considered.
• People who are not considered medically suitable for treatment with pembrolizumab alone or combined with platinum-based chemotherapy, including people with active infections, autoimmune diseases, conditions requiring immune-suppressing medications (such as organ transplant recipients), a history of severe immune-related reactions, or a known allergy to pembrolizumab or any of its ingredients. People with pre-existing conditions such as colitis, liver problems, breathing disorders, or hormonal conditions (such as thyroid disorders or diabetes) may still be considered, provided their doctor determines pembrolizumab can be given with appropriate caution and monitoring. People must also have no medical reasons preventing them from receiving platinum-based chemotherapy.
• People with a significant history of neurological or psychiatric conditions that would prevent them from giving informed consent or from following the trial requirements.
• People currently receiving any other cancer treatment or participating in another cancer treatment trial.
• People who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.